Saturday, June 9, 2012

J&J submitted its next-gen diabetes compound to FDA last week -- backed by a massive 10,000 patient clinical trial data set. Today, at the ADA meeting being held in Philadelphia, the public got a look at how much stronger than Merck's (and many others') current stars this next generation candidate -- called by its chemical name, canagliflozin (not yet J&J branded) -- is likely to be. It seems to avoid some of the obesity risk present in the older medication regimes (or, it may actually be a weight-loss drug-effect -- etiher way, it is very good news).

This all may give Merck only about 9 to 12 months of remaining ascendency in the diabetis franchise -- for Januvia®/Janumet®. Per Reuters, today:

. . . .An experimental treatment for type 2 diabetes developed by Johnson & Johnson demonstrated greater reduction in blood sugar than Merck & Co's Januvia and an older common treatment, glimepiride, according to data from a pair of late stage clinical trials.

The J&J drug, canagliflozin, also led to significantly greater weight loss than both of the other drugs and far fewer incidents of hypoglycemia, or potentially dangerous drops in blood sugar levels, than glimepiride, a member of the sulfonylurea class of medicines.

Weight loss is an especially attractive effect as obesity is a leading cause of type 2 diabetes and some older medicines cause weight gain.

Canagliflozin, belongs to a new class of diabetes treatments called SGLT2 inhibitors that work by blocking reabsorption of glucose by the kidney and increases glucose excretion in the urine to lower blood sugar. . . .

This will be fascinating -- will Merck open off, on the NYSE Monday -- on this news? We shall see, but the combined franchise accounted for $4.68 billion in worldwide revenue in 2011 -- growing in the higher 30's -- as a percentage, year over year -- so that makes it arguably material, on the revenue-line, for Merck (on total sales of $48 billion, that's approaching 10 percent). The arc of this up-ramp is almost certainly going to drop-off, when the J&J candidate reaches market -- perhaps in early 2013.

Januvia could helps certain people with diabetes to keep their blood sugar level under control by encouraging the body to use blood sugar more effectively. Januvia controls the body's sugar level constantly.

More FDA Resources. . .

Blog Archive

Senator Grassley's Concern

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FDA Drug Facts

The Condor. . . .

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